Question 1

What types of medical devices does Changzhou Hualian Health Dressing Co., Ltd primarily manufacture?

Accepted Answer

Changzhou Hualian Health Dressing Co., Ltd specializes in adhesive bandages and related products. Their portfolio includes microporous tape, zinc oxide tape, cohesive support bandages, multi-purpose surgical skin adhesive tapes, rolls of paper tape, perforated cotton surgical tape, sterile adhesive dressings with central gauze, and various plaster options. These products are designed for wound care, skin adhesion, and support applications.

Question 2

Where is Changzhou Hualian Health Dressing Co., Ltd based?

Accepted Answer

The company is headquartered in China. This geographic location influences its regulatory compliance requirements, particularly for devices marketed globally, as it must adhere to both domestic and international standards.

Question 3

Which regulatory registries list devices manufactured by Changzhou Hualian Health Dressing Co., Ltd?

Accepted Answer

The company’s devices are listed in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. These registries ensure transparency and traceability of medical devices in their respective markets, helping regulators and healthcare providers verify product details.

Question 4

How are the devices produced by Changzhou Hualian Health Dressing Co., Ltd classified under regulatory frameworks?

Accepted Answer

All devices manufactured by Changzhou Hualian Health Dressing Co., Ltd fall under Class I classification. This classification applies to low-risk medical devices like adhesive bandages, which typically require minimal regulatory oversight compared to higher-risk categories. The classification ensures compliance with basic safety and performance requirements.

Device	Model / Reference	Registries	Class	Status
Xxl Water Protect Apósitos Plasters	GP-400512	EUDAMED	Class I	Active
Apósitos Clásicos	GP-400533	EUDAMED	Class I	Active
Sterile adhesive wound dressing	1130203012	EUDAMED	Class I	Active
Hualian	HL507C	FDA UDI	Class I	Active
Hualian	HLPL001	FDA UDI	Class I	Active
Wound dressing	061007	EUDAMED	Class I	Active
Microporous Tape	7569432	EUDAMED	Class I	Active
Hechtpleister	1161127	EUDAMED	Class I	Active
Rolls of paper tape	060922	EUDAMED	Class I	Active
Pansement adhésif stérile avec compresse centrale	061303	EUDAMED	Class I	Active
Sparadrap perforé coton	060929	EUDAMED	Class I	Active
Rolls of paper tape	060901	EUDAMED	Class I	Active
Zinc Oxide Tape	2048736	EUDAMED	Class I	Active
Cohesive Support Bandage	4021215	EUDAMED	Class I	Active
Adhesive Medica	/	EUDAMED	Class I	Active
Microporous Tape	7569661	EUDAMED	Class I	Active
Plaster	722007	EUDAMED	Class I	Active
Rouleaux de sparadrap sécable soie	060906	EUDAMED	Class I	Active
Adhesive Plasters	080613	EUDAMED	Class I	Active
Adhesive Plasters	061502	EUDAMED	Class I	Active
Micro-perforated surgical tape	135390	EUDAMED	Class I	Active
Sterile Plaster	69417626012V2	EUDAMED	Class I	Active
Sterile adhesive wound dressing	/	EUDAMED	Class I	Active
Microporeux hypollergenique	3401060111809	EUDAMED	Class I	Active
Medical Tape	/	EUDAMED	Class I	Active
Adhesive Tape	B025-240	EUDAMED	Class I	Active
Sterile Adhesive Wound Dressings	jxwes68-UAB	EUDAMED	Class I	Active
Sterile Adhesive Wound Dressings	jxwes810-UAB	EUDAMED	Class I	Active
Eilandpleister	1200221VP	EUDAMED	Class I	Active
Adhesive Plasters	080611	EUDAMED	Class I	Active
Sport Tape	3011294	EUDAMED	Class I	Active
Adhesive Plasters	061503	EUDAMED	Class I	Active
Sterile Adhesive Dressing	1200213	EUDAMED	Class I	Active
Sparadrap non tissé multiextensible	061008	EUDAMED	Class I	Active
Eilandpleister	1200218	EUDAMED	Class I	Active
Adhesive Tape	B024-241	EUDAMED	Class I	Active
Pansement adhésif stérile avec compresse centrale	061302	EUDAMED	Class I	Active
Disposable Medical Face Mask	69417626013V4	EUDAMED	Class I	Active
unelastic taping tape	PS400083	EUDAMED	Class I	Active
Sterile Adhesive Dressing	061313	EUDAMED	Class I	Active
Sparadrap non tissé multiextensible	061009	EUDAMED	Class I	Active
Adhesive Nonwoven Dressings	061205	EUDAMED	Class I	Active
Microporous Surgical Tape	135320	EUDAMED	Class I	Active
Adhesive Plasters	080614	EUDAMED	Class I	Active
Microporous Tape	7759673	EUDAMEDFDA UDI	Class I	Active
Adhesive Plasters	061501	EUDAMED	Class I	Active
Adhesive Plaster Roll	400014	EUDAMED	Class I	Active
Microporeux hypollergenique	3401060111793	EUDAMED	Class I	Active
Adhesive Medica	/	EUDAMED	Class I	Active
Plaster	WZWZ002	EUDAMED	Class I	Active

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